GAMMA 3425-1400SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252273851), received between Jul 2, 2018 and Jul 21, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6) 2021 THE PATIENT TRIPPED AND FELL AND ON (B)(6) 2021 SHE PRESENTED FOR TREATMENT AND WAS DIAGNOSED WITH A RIGHT SUBTROCHANTERIC FEMUR FRACTURE. ALLEGEDLY ON (B)(6) 2021 SHE UNDERWENT AN INTRAMEDULLARY NAIL FIXATION AND CERCLAGE WIRING IN THE SUBTROCHANTERIC REGION UTILIZING GAMMA 3. ALLEGEDLY ON (B)(6) 2021 THE PATIENT DEVELOPED SUDDEN ONSET OF SEVERE PAIN IN THE RIGHT HIP AND IT WAS NOTED THE PROXIMAL ASPECT OF THE ROD WAS FRACTURED AT THE LOCATION OF THE PROXIMAL COMPRESSION SCREW AND DISTAL INTERLOCKING SCREW WAS FRACTURED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 15072814 ↗
• InjuryDec 6, 2019Fracture; Fracture

  AS REPORTED: "LONG GAMMA NAIL WITH 2 DALL MILES CABLES. PROXIMAL PORTION OF THE NAIL BROKE. REVISION SURGERY REQUIRED."

  Patient problems: Failure of Implant; Injury

  MAUDE report 9434352 ↗
• InjuryJul 2, 2018Collapse

  AS REPORTED: "THE PATIENT HAD A LONG GAMMA IMPLANTED APPROX. 8 YEARS AGO AT (B)(6). THE PATIENT FELL LAST WEEK AND THE FEMORAL HEAD COLLAPSED. THE SURGEON DECIDED TO REMOVE THE GAMMA NAIL AND DO A PRIMARY THA USING ACCOLADE II SIZE 5 AND A TRIDENT HA HEMI CUP 52MM. ROUTINE PROCEDURE WITH NO COMPLICATIONS".

  Patient problems: Fall

  MAUDE report 7655716 ↗